Lack of independence in the EUs cancer assessment of glyphosate - - PowerPoint PPT Presentation

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Lack of independence in the EUs cancer assessment of glyphosate - - PowerPoint PPT Presentation

Jun 24, 2023 384 likes •972 views

Lack of independence in the EUs cancer assessment of glyphosate Helmut Burtscher-Schaden, GLOBAL 2000 - Friends of the Earth, Austria The best pesticide law in the world (Regulation (EC) No 1107/2009) The best pesticide law in the

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SLIDE 1

Lack of independence in the EU‘s cancer assessment of glyphosate

Helmut Burtscher-Schaden, GLOBAL 2000 - Friends of the Earth, Austria

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SLIDE 2

„The best pesticide law in the world“

(Regulation (EC) No 1107/2009)

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SLIDE 3

„The best pesticide law in the world“

(Regulation (EC) No 1107/2009)

  • 1. Hazard-based cut-off criteria for active substances
  • f very high concern
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SLIDE 4

„The best pesticide law in the world“

(Regulation (EC) No 1107/2009)

  • 1. Hazard-based cut-off criteria for active substances
  • f very high concern
  • 2. Mandatory assessment of the scientific literature
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SLIDE 5

„The best pesticide law in the world“

(Regulation (EC) No 1107/2009) independent, objective and transparent assessment (Article 11)

  • 1. Hazard-based cut-off criteria for active substances
  • f very high concern
  • 2. Mandatory assessment of the scientific literature
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SLIDE 6

Evaluation of long- term carcinogenicity studies with mice

example no.1

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SLIDE 7

limited evidence inade- quate evidence

Sufficient evidence

Cancer

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SLIDE 8

limited evidence inade- quate evidence

Sufficient evidence

Cancer

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SLIDE 9

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

GTF submitted it‘s dossier ...

In May 2012,

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SLIDE 10

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

.. and stated that...

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SLIDE 11

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

… „glyphosate is not carcinogenic“ ...

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SLIDE 12

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

slightly elevated but incidental

Malignant

Lymphoma

… „glyphosate is not carcinogenic“ ...

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SLIDE 13

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

slightly elevated but incidental

Malignant

Lymphoma

BfR agreed with GTF ...

in Dec 2013

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SLIDE 14

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

slightly elevated but incidental

Malignant

Lymphoma

BfR agreed with GTF ...

in Dec 2013

✓ ✓ ✓ ✓

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SLIDE 15

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

Malignant

Lymphoma „ „.. only very limited evidence .. only very limited evidence

  • f carcinogenic potential“
  • f carcinogenic potential“

BfR agreed with GTF ...

in Dec 2013

slightly elevated but incidental

✓ ✓ ✓ ✓

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SLIDE 16

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

Malignant

Lymphoma „ „.. only very limited evidence .. only very limited evidence

  • f carcinogenic potential“
  • f carcinogenic potential“

BfR agreed with GTF ...

in Dec 2013

“ [t]he weak increase in malignant lymphoma [..] was clearly confined to this single study and [..] not reproducible in four

  • ther studies ..“

slightly elevated but incidental

✓ ✓ ✓ ✓

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SLIDE 17

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

Malignant

Lymphoma „ „.. only very limited evidence .. only very limited evidence

  • f carcinogenic potential“
  • f carcinogenic potential“

“ [t]he weak increase in malignant lymphoma [..] was clearly confined to this single study and [..] not reproducible in four

  • ther studies ..“

BfR agreed with GTF ...

in Dec 2013

slightly elevated but incidental

✓ ✓ ✓ ✓ ✓

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SLIDE 18

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

→ →

Glyphosate is not Glyphosate is not carcinogenic in mice carcinogenic in mice

Malignant

Lymphoma „ „.. only very limited evidence .. only very limited evidence

  • f carcinogenic potential“
  • f carcinogenic potential“

“ [t]he weak increase in malignant lymphoma [..] was clearly confined to this single study and [..] not reproducible in four

  • ther studies ..“

MS and EFSA agreed with BfR in

slightly elevated but incidental

✓ ✓ ✓ ✓ ✓

Feb 2015

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SLIDE 19

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

In , IARC found „sufficient evidence“ ...

Mar 2015

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SLIDE 20

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase

In , IARC found „sufficient evidence“ ...

Mar 2015

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SLIDE 21

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase

In , BfR agreed with IARC

Aug 2015

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SLIDE 22

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase

In , BfR agreed with IARC

Aug 2015

✓ ✓

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SLIDE 23

Monsanto 1983 Cheminova 1993

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322)

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase

✓ ✓

In , BfR agreed with IARC

Aug 2015 Arysta 1997 Adama 2001 Nufarm 2009

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SLIDE 24

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322

… and confirmed 8 significant tumor findings

✓ ✓ ✓ ✓

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SLIDE 25

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322

✓ ✓ ✓ ✓ ✓

… and confirmed 8 significant tumor findings

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SLIDE 26

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322

Statistically significant increase Statistically significant increase Statistically significant increase

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

… and confirmed 8 significant tumor findings

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SLIDE 27

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322

Statistically significant increase Statistically significant increase Statistically significant increase

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

How to overlook 7 cancer findings?

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SLIDE 28

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

Source: RAR, Dec. 2013 (Vol 1, Page 74 of 4322

Statistically significant increase Statistically significant increase Statistically significant increase

How to overlook 7 cancer findings?

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

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SLIDE 29

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

How to overlook 7 cancer findings?

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

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SLIDE 30

Monsanto 1983 Cheminova 1993 Arysta 1997 Adama 2001 Nufarm 2009

Malignant

Lymphoma Kidney tumors Haemangio- sarcoma

Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase Statistically significant increase

How to overlook 7 cancer findings?

✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

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SLIDE 31
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limited evidence Inade- quate evidence

sufficient evidence

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SLIDE 33

“[T umours] could be considered treatment related”

limited evidence Inade- quate evidence

sufficient evidence

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SLIDE 34

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related”

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SLIDE 35

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity”

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SLIDE 36

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity”

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SLIDE 37

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity” “..the evidence of carcinogenicity is conclusive ...

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SLIDE 38

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity” “..the evidence of carcinogenicity is conclusive ...

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SLIDE 39

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity” “..the evidence of carcinogenicity is conclusive but not suffjcient for classifjcation”

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SLIDE 40

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity” “..the evidence of carcinogenicity is conclusive but not suffjcient for classifjcation”

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SLIDE 41

limited evidence Inade- quate evidence

sufficient evidence

“[T umours] could be considered treatment related” “Based on these criteria it is obvious that IARC concludes on suffjcient evidence of carcinogenicity” “..the evidence of carcinogenicity is conclusive but not suffjcient for classifjcation”

?

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SLIDE 42
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SLIDE 43

Evaluation of the Scientific Literature

  • n Genotoxicity

example no.2

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SLIDE 44
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SLIDE 45

limited evidence Inade- quate evidence

Strong evidence

Genotoxicity

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SLIDE 46

limited evidence Inade- quate evidence

Strong evidence

Genotoxicity

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SLIDE 47
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SLIDE 48

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

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SLIDE 49

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

TRADE SECRET TRADE SECRET

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SLIDE 50

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

TRADE SECRET TRADE SECRET

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SLIDE 51

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

TRADE SECRET TRADE SECRET

n=72

Published Studies

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SLIDE 52

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

TRADE SECRET TRADE SECRET

n=72

Published Studies

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SLIDE 53

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

TRADE SECRET TRADE SECRET

n=72

Published Studies

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SLIDE 54

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies RELIABLE & RELEVANT RELIABLE & RELEVANT

n=72

Published Studies

NOT RELIABLE NOT RELIABLE

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SLIDE 55

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

n=72

Published Studies

NOT RELIABLE NOT RELIABLE

RELIABLE & RELEVANT RELIABLE & RELEVANT

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SLIDE 56

DNA-damage reported DNA-damage not reported inconclusive

Industry Studies

n=72

Published Studies

NOT RELIABLE NOT RELIABLE

?

RELIABLE & RELEVANT RELIABLE & RELEVANT

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SLIDE 57
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SLIDE 58

Thank you for your attention